Coronavirus infection may soon be reported through a breath of breath, after the Food and Drug Administration authorized the first breath-based Covid-19 test in the United States on Thursday.
Experts said the emergency use authorization for the InspectIR Covid-19 Breathalyzer is an important milestone in the years-long quest to develop more breath-based diagnoses, as well as innovative new tests for Covid. It is likely to be the first of many breath-based Covid tests, experts said.
“I think this is a really exciting development for the entire field of breath analysis,” said Christina Davis, vice president of interdisciplinary research and strategic initiatives at the University of California, Davis, which is developing its own coronavirus test. “This is a huge step forward.”
The scientists said breath tests remain challenges in the real world, and this particular device has many practical limitations. The machine required to perform the tests is large – the size of a handbag – and can only be used by trained operators who are supervised by healthcare professionals.
Many devices will be needed for large-scale screening, given that each machine can only process about 20 samples per hour, according to InspectIR Systems, a small five-person company based in Frisco, Texas.
The company cited high accuracy rates for its tests, but some experts said they wanted to examine the data behind its application to the Food and Drug Administration before adopting this test method.
In addition, many healthcare settings and mobile testing sites where the devices can be used have already adopted other types of rapid testing, which are now widely available. InspectIR officials said that final pricing plans have not yet been set.
It could take 10 to 12 weeks for the first devices to reach market, John Redmond, co-founder of InspectIR Systems, said Friday. The company said it plans to produce about 100 devices per week, according to the Food and Drug Administration, but it was not immediately clear when production would reach that level. Dr. Wilbur Lamm, a pediatric hematologist and bioengineer at Emory University and Georgia Tech and an expert in Covid testing said.
“The devil is in the details to determine how useful this thing is,” he said.
Many diseases cause physiological changes that alter the compounds we exhale, and there has long been interest in developing breath tests for a wide range of diseases, from lung cancer to liver disease.
When the epidemic began, many research teams began trying to identify the unique chemical patterns in the breath of Covid patients, and many scientists and companies developed breath-based coronavirus tests, which can be used to screen large groups of people quickly and without surgical intervention. virus.
Some Covid breath tests have already been tested in pilot programs or authorized for use in other countries, but the InspectIR Breathalyzer will be the first to hit the market in the United States.
To use the device, patients blow into a cardboard straw attached to a chemical analyzer. “It’s a chemistry lab in a box,” said Mr. Redmond. Mr Redmond said the machine then analyzes levels of five volatile organic compounds, or volatile organic compounds, which together form a “breathing fingerprint” of Covid. (InspectIR said it cannot reveal what the five complexes are.) The company said results are delivered within three minutes.
“This is really fast and impressive,” said Nathaniel Haver, a molecular biologist and testing expert at UMass Chan School of Medicine.
He added that expanding on the types of samples that can be used to detect the virus is “really helpful”. “Not everyone can provide a nose sample very easily.”
In a company-sponsored study of 2,409 people without symptoms, the alcohol meter had a sensitivity of 91 percent, meaning that of the people who tested positive for the virus on a PCR test, the device identified 91 percent as positive, according to the documents. The ones released by the FDA have a specificity of 99 percent, which means that it detected no signs of the virus in 99 percent of those who received a negative PCR test.
Susan Butler-Wu, a clinical microbiologist at the University of Southern California’s Keck School of Medicine, said she wanted to see more independent data on the device’s performance and more details about exactly which compounds it was detecting.
“The use of VOCs has not been well developed for the diagnosis of infection,” she said. “I wouldn’t feel comfortable using it to diagnose patients without having more realistic data.”
Scientists have indicated that certain foods and substances can impair breathing tests. The instructions for the InspectIR Breathalyzer state that people should not eat, drink, or use any tobacco products within 15 minutes before the test. The company says that those who test positive for the virus should have a PCR or other similar test result.
In fact, the most promising way to use breath tests is as a rapid screening tool — a more accurate version of the unreliable temperature monitors that have become popular during the pandemic, Dr. Lam said. “They don’t really give you a diagnosis,” he said, referring to the breath tests. “They give you a biochemical pattern that corresponds to the disease.”
InspectIR hopes to lease the analyzers to other companies, including healthcare facilities and companies that operate mobile or pop-up test sites. The founders said they could be used to test travelers at airports or workers in an office building, adding that there was already interest from professional sports associations and companies in the travel industry.
“Anywhere they do a nasal swab more than once a day, we have a good fit,” said Tim Wing, co-founder of the company.
Pricing for the device has yet to be finalized, but the co-founders said Friday they hope to be able to offer licenses or subscriptions that translate at a cost of between $10 and $12 per test.
“Yesterday was a huge domino for us,” Mr. Wing said Friday, the day after the device was licensed. “Not all of these things are ready to go, they haven’t been determined yet.”
The company said it has raised $2.7 million so far and that Pfeiffer Vacuum will be its initial manufacturing partner.